The prostate is a male reproductive gland. Benign Prostate Hypertrophy (BPH) or prostate enlargement is a condition of aging. According to the National Institutes of Health (NIH), BPH affects more than 50% of men over the age of 60 and as many as 90% of men over the age of 70. The increase in size of the prostate gland that occurs with BPH exerts pressure on the urethra, resulting in obstruction and difficulty with urine flow.
The exact cause of BPH is uncertain. It is possible that the condition is associated with hormonal changes that occur as men age. The testes produce the hormone testosterone, which is converted to dihydrotestosterone (DHT) and estradiol (estrogen) in certain tissues. High levels of dihydrotestosterone, a testosterone derivative involved in prostate growth, may accumulate and cause hypertrophy. How and why levels of DHT increase remain a subject of research. However, approaches to block 5 alpha reductase and therefore the conversion of testosterone to DHT (dihydrotestosterone) are shown to be effective in treating BPH.
The symptoms of BPH result from the impact the prostate enlargement has on the bladder and lower urinary tract. Common symptoms include dribbling after voiding; feeling that the bladder has not emptied completely after urination; frequent urination, particularly at night (i.e., nocturia); a hesitant, interrupted, or weak urine stream caused by decreased force; leakage of urine (i.e., overflow incontinence); the need for pushing or straining to begin urination; recurrent, sudden, urgent need to urinate; irritated bladder or urethra; blood in the urine (i.e., hematuria), caused by straining to void.
Prostatitis is a term that describes inflammatory conditions of the prostate gland. Bacterial infections are the cause in many cases, but evidence of infection is not always found. Prostatitis can affect men of any age and it is estimated that 50% of men experience the disorder during their lifetime. Prostatitis is the most common urological disorder in men over the age of 50 years old and the third most common disorder in men younger than 50 years old. There are four types of prostatitis: acute bacterial prostatitis (ABP) is inflammation of the prostate gland caused by bacteria such as Escherichia coli and Klebsiella; chronic bacterial prostatitis (CBP) is a recurrent infection and inflammation of the prostate and urinary tract; nonbacterial prostatitis is an inflamed prostate without bacterial infection; and prostatodynia, sometimes called chronic pelvic pain syndrome (CPPS), is the occurrence of prostatitis symptoms, without inflammation or bacterial infection.
Prostatic intraepithelial neoplasia (PIN) has been identified as a precursor lesion to prostatic carcinoma. PIN refers to the precancerous end of a morphologic spectrum involving cellular proliferation within prostatic ducts, ductules, and acini. Bostwick and Brawer introduced the term PIN in 1987. At an international conference in 1989, the term PIN replaced a variety of terms (e.g. intraductal hyperplasia, hyperplasia with malignant change, large acinar atypical hyperplasia, marked atypia, ductal-acinar dysplasia). The frequency of PIN in men with prostate cancer is significantly higher than in those without cancer. PIN appears to precede cancer by more than 10 years, with a parallel age-related increase in the frequency of PIN and cancer. PIN has been found in 9% of men in the second decade of life, 22% of men in the third decade, and 40% of men in the fourth decade. By the time men reach age 80 years old, the prevalence of PIN is 70%.
Symptoms of the above prostate disorders are similar. Common symptoms are urinary and include dribbling after voiding; feeling that the bladder has not emptied completely after urination; frequent urination, particularly at night (i.e., nocturia); hesitant, interrupted, or weak urine stream caused by decreased force; leakage of urine (i.e., overflow incontinence); pushing or straining to begin urination; recurrent, sudden, urgent need to urinate; and blood in the urine (i.e., hematuria) caused by straining to void.
There are two main classes of drugs that are prescribed for treating prostate disorders: alpha-blockers and 5-alpha-reductase inhibitors.
Alpha-blockers relax the smooth muscles of the arteries, the prostate, and the bladder neck. Relaxing the smooth muscles around the bladder neck helps relieve urinary obstruction. While alpha-blockers help alleviate some of the symptoms, this drug does not cure BPH. There are several different alpha-blockers. Currently, these are alfuzosin (Xatral), doxazosin (Cardura), indoramin (Doralese), prazosin (Hypovase), terazosin (Hytrin BPH), and tamsulosin (Flomax MR). Side effects can include headaches, dizziness, low blood pressure, fatigue, weakness, and difficulty breathing. Long-term risks and benefits have not been studied.
5-Alpha-reductase inhibitors inhibit the production of the enzyme that converts testosterone to DHT. Thus, 5-alpha-reductase inhibitors are able to reverse BPH to some extent and shrink the prostate. Side effects include reduced libido, impotence, problems with ejaculation, breast tenderness and enlargement, and reduced sperm count. Long-term risks and benefits have not been studied. Safety of 5 alpha reductase inhibitors is a concern for pregnant women who may be exposed to broken capsules, and patients on this medication should stop for 6 months before donating blood.
Surgery is also an option for relief of symptoms of BPH and prostatitis and is recommended for patients who experience serious complications, and has the most complications including urinary incontinence, overactive bladder and a possible worsening of urinary symptoms as well as impotence, retrograde ejaculation (dry climax), and possibly sterility. Prostatectomy complications include incontinence and impotence.
Natural therapies may be used to treat prostate disorders. Saw palmetto (i.e. Serenoa repens) acts as a 5-alpha-reductase inhibitor reducing the production of DHT and also preventing DHT from binding to the prostate. Schneider et al., Fortschr. Med. 113: 37-40 (1995); Kock and Biber, Urologe 334: 90-95 (1994). Side effects include mild digestive distress as well as some of the side effects associated with the 5-alpha-reductase inhibiting drug medications, such as mild pruritis, headache, hypertension, erectile dysfunction, ejaculatory disorders, and decreased libido. Pygeum (Pygeum africanum) contains three compounds that may help the prostate: pentacyclic triterpenoids, which have a diuretic action; phytosterols, which have anti-inflammatory activity; and ferulic esters, which help rid the prostate of any cholesterol deposits that accompany BPH. Andro and Riffaud, Curr. Ther. Res. 56: 796-817 (1995). Stinging nettles (Urtica dioica) can also reduce BPH symptoms and may increase urinary volume and the maximum flow rate of urine in men with early-stage BPH. Kock and Biber, Urologe 334:90-95 (1994). Side effects include digestive distress.
All of the mentioned treatment options for prostate disorders have some associated side effects. Pharmaceutical drug and herbal treatment options commonly do not completely resolve symptoms of urinary incontinence and overactive bladder that may be associated with the disorders. The bladder and urethra are significantly impacted by BPH, contributing to long term weakness in this area and resultant impaired bladder tone and function.
There is currently a need for new compositions for the prevention and treatment of prostate disorders with emphasis not just on the prostate but also on the bladder and its associated symptoms, including overactive bladder (OAB), nocturia, poor urinary stream and urinary incontinence (UI). There is a need for these new compositions without many of the unwanted side effects. There is also a need for these improvements in prostate and bladder symptoms to occur within a shorter time frame of weeks rather than many months.